Eight more ‘dark particles’ batches recalled

recall regulatory

Apotex, in consultation with the TGA, is extending its Apo-Perindopril Arginine recall

Eight more batches of the drug are being recalled due to potential contamination with dark particles of silica.

These particles are “presumably released from the desiccant cylinder that is placed inside the bottle to keep the contents dry and protected from moisture,” the TGA and Apotex said when the initial recall was made.

The particles may be large enough to see as specks or appear as a dust that discolours the tablets themselves and/or the inside of the bottle.

This potential contamination is classified as a quality defect and is not considered to impact product safety or efficacy.

The dark particles may appear as small specks at the bottom of the image and a light dusting on the tablets themselves.

Apo-Perindopril Arginine 2.5 mg:

  • NC6619 EXP 02/2020
  • NC6620 EXP 02/2020
  • MX1699 EXP 05/2019
  • MX1697 EXP 05/2019

Apo-Perindopril Arginine 5 mg:

  • NC6671 EXP 03/2020
  • NC6670 EXP 03/2020
  • MX1702 EXP 05/2019
  • NC6672 EXP 03/2020

Apo-Perindopril Arginine 10 mg:

  • MX1705 EXP 05/2019
  • MX1703 EXP 05/2019
  • MX1704 EXP 05/2019

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